The drug Aplidin®(plitidepsin), which is already approved in Australia for the treatment of multiple myeloma also appears to have antiviral qualities. The drug is therefore now being submitted for Phase II clinical trials for the treatment of hospitalised patients with COVID-19, or to give the virus it's full name SARS-CoV-2.
SARS-CoV-2 uses a protein called eEF1A, which is present in human cells to reproduce and infect other cells. It is reported that the new drug acts by blocking this protein.
APLICOV clinical trial protocol
The trial protocol has already been given the name 'APLICOV' and has been submitted to the Spanish Medicines and Healthcare Products Agency. The company states that, "The trial is a multicenter, randomized Phase II clinical trial, in which two different doses of plitidepsin will be evaluated for the treatment of patients with COVID-19 pneumonia. The protocol is currently being evaluated".
Effective weapon against COVID-19
The protocol includes 160 patients admitted to hospitals in Spain, where it is intended to assess whether plitidepsin, administered intravenously for 5 days to patients with COVD-19 pneumonia, reduces the proportion of patients who progress to Acute Respiratory Distress Syndrome (ARDS), the main cause of patients requiring mechanical ventilation and/or admission to Intensive Care Units.
Several Spanish centers are due to participate in the study and which is expected to start as soon as the authorization from the Health Authorities is obtained.
On March 13th, the Company announced the results of in vitro studies of plitidepsin in human coronavirus HCoV-229E, with a mechanism of multiplication and propagation that is very similar to that of SARS-CoV-2.
Plitidepsin acts by blocking the protein eEF1A, present in human cells, which is used by SARS-CoV-2 to reproduce and infect other cells. By means of this blocking, the reproduction of the virus inside the cell is prevented, making its propagation to the rest of the organism’s cells, unfeasible.
José María Fernández, President of PharmaMar says, "... we will be able to start the clinical trial with plitidepsin and we hope that it can become an effective weapon against COVID-19".
However, even if the trials go well, as this is still only at Phase II it is worth noting that it will be some time before this drug is approved and becomes widely available as an antiviral.